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Completed

NCT Number: NCT01663909

Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion

Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain management a complex task. Several studies have found out that pharmacological interventions alone were not enough to provide optimal pain management for these patients. The investigators developed a DVD on guided imagery, customized for teenagers, to help them cope better with their pain. The investigators believe that this type of intervention combined with their usual analgesic medication will help them to control their pain and foster rehabilitation.

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Key information

Age range

11 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Ste-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 11 and 20 years old
  • Have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis
  • Able to write and understand French
  • Requires a computer or DVD player at home.

Exclusion criteria

  • Diagnosed with a moderate cognitive deficit or severe mental retardation

Treatment and study plan

Guided imagery intervention

Behavioral

A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.

Primary outcomes

  1. Level of pain intensity

    Time frame: Level of pain intensity at two weeks after the surgery

    Pain was measured before the patients left the hospital on their 7th postoperative day (T-1, time of discharge from hospital). It was measured again at two week post-discharge (T-2) and also at one month post-discharge (T-3) on their visit to the orthopedic clinic. Our primary outcome was at T-2.

Secondary outcomes

  1. Level of anxiety

    Time frame: Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery

    Anxiety was measured as baseline data on the pre-operative visit (24 hrs before surgery). It was also measured at two weeks post-discharge and at one month on the day of the visit to the orthopedic clinic.

  2. Level of coping

    Time frame: Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery

    Coping strategies of adolescents regarding their pain management were also measured pre-operatively (24 hrs before surgery), at two weeks and one month post-surgery.

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2012
Registry last updated
Aug 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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